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Biotech / Medical : CEPH -- Ignore unavailable to you. Want to Upgrade?

To: bysfbay who wrote (482)	11/4/1997 9:01:00 PM
From: WeirdPro Randy	Respond to of 998

<<Over two months ago, an FDA advisory board recommended (to the FDA approval board by majority vote) not to give CEPH approval of Myotrophin. >> Besides the fact that the advisory panel never voted for or against the approval of myotrophin, which means the FDA would not have to go against a panel decision to approve myotrophin, Cephalon has since provided new and improved evidence from patients in the T-Ind study. In addition, the FDA is under intense pressure and scrutiny from Congress at this time for which disapproval would be met with severe repercussions. There is sufficient information to warrant the NDA approval, as well as ethical and political reasons.

To: bysfbay who wrote (482)	11/5/1997 10:19:00 AM
From: Brian Pastor	Read Replies (2) \| Respond to of 998

Read the WSJ archives. It reported on Congressional hearings where the tenor was heavy criticism of the FDA for its decision on this particular drug. Heavy political and public pressure on FDA to not follow the advisory board recommendation. While the FDA almost always follows the recommendation of the advisory panel, it certainly does not have to and there is precedent of it having not followed recommendations in the past. I agree, that this decision is not a lock in CEPH's favor, but I found it tremendously interesting that well over a thousand calls at the 12.5 strike price traded yesterday, while I saw NO Nov. 12.5 puts traded at all (up to 3 pm that is). This indicates that something may have leaked out of the FDA already becuase otherwise, I would have expected betting on BOTH sides. However, having said that, I am not putting any money on this issue until AFTER the FDA decision is released. Becuase if it is favorable, CEPH will likely gap back up into the 20 - 30 range and there will be time to jump back in. If the fDA decision is negative. Watch out for the crash on this issue.